The U.S. Food and Drug Administration (FDA) has put a clinical hold Denali Therapeutics’ application to begin clinical testing of DNL919, an immune-modulating medication that the company is developing to treat Alzheimer’s disease. The FDA will issue an official clinical hold letter to Denali in the next month or so, according to a company press…
Longeveron is initiating a Phase 2a clinical trial for its Lomecel-B treatment — an investigational, bone marrow-derived, medicinal signaling cell (MSC) — in patients with mild Alzheimer’s disease. The first patient has already given consent to participate in the trial, and further patient screening has begun. “We are pleased to have initiated this Phase 2a…
Cassava Sciences has launched a new website, called Rethink-ALZ.com, to make it easier for anyone interested to access information about two Phase 3 clinical studies of simufilam, the company’s oral investigational therapy for mild-to-moderate Alzheimer’s disease. The trials, dubbed RETHINK-ALZ and REFOCUS-ALZ, are ongoing in the U.S. and Canada, and both are currently recruiting patients with…
A new proposal in the U.S. that Medicare cover the cost of Aduhelm (aducanumab) only for people enrolled in qualifying clinical trials has been met with outrage from the Alzheimer’s Association and decried by Biogen, which developed the treatment alongside Eisai. Issued by the U.S. Centers for Medicare and Medicaid Services (CMS), the proposed National…
An international clinical trial for gantenerumab aimed at preventing inherited, early-onset Alzheimer’s disease is being launched at the Washington University School of Medicine in St. Louis. The trial, called the Primary Prevention Trial, is enrolling people with a family history of early-onset Alzheimer’s and its associated genetic mutations up to 25 years before their expected onset…
To ensure that dementia patients and their caregivers have proper support and information, the Alzheimer Society of Canada is calling attention to its First Link program, designed to share a key message: “You are not alone.” The Canada-wide campaign, announced in January during the country’s Alzheimer’s Awareness Month, seeks to remind those with dementia or…
Acadia Pharmaceuticals intends to again request that oral Nuplazid (pimavanserin) be approved to treat hallucinations and delusions, but this time only when associated with the dementia-related psychosis of Alzheimer’s disease. Its planned request to the U.S. Food and Drug Administration (FDA), in the form of a resubmitted supplemental new drug application (sNDA), follows the FDA’s rejection last year of…
Lecanemab, an investigational antibody also known as BAN2401, has been granted a fast track designation from the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. The antibody, developed jointly by Biogen and Eisai, is designed to bind to the protein amyloid-beta. This potentially…
Alzheimer’s News Today brought you coverage of the latest scientific advances, developments in treatment, and clinical trials related to Alzheimer’s disease throughout 2021. We look forward to continuing to report important news for the Alzheimer’s community this year. Here are the top 10 most-read Alzheimer’s stories of 2021. No. 10 – “1st Phase 3 Simufilam Trial…
While calling the recent decision to slash by about half the U.S. list price for Aduhelm (aducanumab) an “important step,” the Alzheimer’s Association continues to advocate for more equitable access to the first new Alzheimer’s therapy since 2003. Specifically, the organization is calling for Biogen, which with Eisai developed and markets Aduhelm, to extend support to early-stage patients whose…
